Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001135303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/08/2026
Date registered
Help: Date registered
11/09/2026
Date last updated
Help: Date last updated
11/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Vibe Up Precision: A Trial Examining Whether Smartphone-Based Digital Markers Can Be Used To Personalise Smartphone-Based Digital Mental Health Interventions for University Students Experiencing Elevated Psychological Distress
Scientific title
Vibe Up Precision: A Four-Arm Randomised Controlled Trial Assessing Digital Phenotyping Predictors of Response to Smartphone-Based Interventions for Psychological Distress Among Australian University Students
Additional trial identifiers [1] 317545 0
Nil
Universal Trial Number (UTN)
U1111-1342-2710
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psychological Distress 342290 0
Condition category
Condition code
Mental Health 338400 338400 0 0
Depression
Mental Health 338401 338401 0 0
Anxiety
Mental Health 339593 339593 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
GENERAL DESIGN
This is a 4-arm randomised controlled trial of 8 weeks duration designed to assess whether digital phenotyping markers are associated with response to brief smartphone-delivered interventions for psychological distress among university students in Australia. Ethical approval for this trial was obtained under a Master Protocol of three methodologically similar trials. This trial registration pertains to 'Trial 1' under this Master Protocol, which will recruit Australian University students.

All intervention content is delivered via a custom-built smartphone-based tool called MindGRID, which monitors the type and timing of intervention content delivered to the participant. The participant-facing intervention content is accessed by participants via the app store though a trial-specific instance of the MindGRID tool called the 'Vibe Up 2.0' app.

Each participant will undergo an initial 2-week pre-intervention period involving twice-daily Ecological Momentary Assessment (EMA; Weeks 1 and 2). Next, participants will be randomly assigned to one of four trial arms (mindfulness, physical activity, sleep hygiene, control) that involve receiving access to their assigned intervention (or control), delivered in a modular manner, over a period of 2 weeks (Weeks 3 and Week 4). Once all intervention modules are released and the 2-week intervention period is complete, participants are provided with continued access to their assigned intervention (or control) for them to continue to review over a 4-week follow-up period (Weeks 5 to 8). Specific details about the pre-intervention EMA and the interventions used in the four trial arms during the intervention period are provided below.

PRE-INTERVENTION EMA
During the 2-week pre-intervention EMA period, all participants will complete EMA twice per day, with each EMA survey expected to take approximately 5 minutes to complete. The EMA will run on a signal-contingent protocol consisting of two daily random prompts to the participant generated by a custom-built smartphone application at a random time within two windows: morning (08:00-10:00) and evening (19:00-21:00). Participants will have up to 60 minutes to respond to the prompt, with a reminder sent after 30 minutes if the prompt has not been responded to.

The EMA questionnaire was designed to provide a comprehensive assessment of anhedonia dynamics, with a particular emphasis on the need to distinguish between the multiple types of anhedonia that exist and the context behind them. To this end, each EMA measurement will consist of:

• An initial question assessing the extent of positive affect that is present at the time.
• Questions designed to elicit the existence of consummatory (i.e., present) anhedonia.
- Social consummatory anhedonia and behavioural (activity-based) consummatory anhedonia will be assessed through separate questions.
- If participants indicate that they are socialising or engaging in an activity, they will be asked whether they are enjoying these activities, how they would usually enjoy them, and how effortful they feel.
- If participants indicate they are not socialising or engaging in an activity, then instead their levels of behavioural and social amotivation will be assessed instead.

• If the EMA is taking place in the evening, further questions will be asked to determine the participant’s level of anticipatory anhedonia:
- Similar to consummatory anhedonia, both social anticipatory anhedonia and behavioural anticipatory anhedonia will be assessed through separate questions.
- Again, if participants indicate that they will be socialising or engaging in an activity, they will be asked whether they are looking forward to these events (anticipatory reward), how motivated they feel to engage in the activity, and how effortful they believe these events will feel.

• A series of open-ended questions that are intended to provide context to the responses above.
- Participants will be asked about what they are doing, and how aspects of this might be considered enjoyable or disappointing,
- If the EMA is being completed in the evening, participants will also be asked how worthwhile/meaningful events that happened in their day was, and what plans they had for tomorrow.
- Participants will be allowed to provide their answers in free text form or via voice recordings.


INTERVENTION PERIOD
At the end of Week 2, participants will be randomised to receive one of three interventions or a control for 2 weeks. These interventions consist of:
a) Brief self-guided smartphone-delivered mindfulness (active intervention)
b) Brief self-guided smartphone-delivered physical activity (active intervention)
c) Brief self-guided smartphone-delivered sleep hygiene (active intervention)
d) Brief self-guided smartphone-delivered EMA (control)
Each intervention is entirely separate but consists of a combination of brief modular information covering key concepts, delivered via infographics, as well as structured activities (e.g., practicing mindfulness using a guided audio). All three active interventions as well as the EMA control have been used recently in the Vibe Up AI-Enhanced Adaptive Trial (trial ID ACTRN12621001223820) and the Vibe Up Precision Pilot Trial (trial ID: ACTRN12625000940471). A summary of the content for each is as follows:

ARM 1: MINDFULNESS
The Mindfulness intervention starts with an introductory module (3 minute video), followed by five guided mindfulness modules delivered as audio recordings (3-5 minutes in length). The content of the modules is as follows:
a) Introductory video: Explains what mindfulness is and the benefits; defines formal vs. informal mindfulness practice; how to tune into the five senses and bring mindful awareness to daily activities; and how to reduce judgment and increase self-compassion.
b) Module 1: Guided mindfulness practice based on mindful awareness of breathing (audio with male/female voice options)
c) Module 2: Guided mindfulness practice teaching non-judgment towards thoughts, using 'leaves on a stream' imagery (audio with male/female voice options)
d) Module 3: Guided mindfulness practice based on mindful awareness of body sensations and releasing of muscle tension (audio with male/female voice options)
e) Module 4: Guided mindfulness practice encouraging the use of all five senses to bring curiosity to everyday activities (audio with male/female voice options)
f) Module 5: Guided mindfulness practice blending awareness of surrounding environment and bodily sensations (audio with male/female voice options)
The modules are made available to participants as follows:
• The introductory video is available to participants immediately after randomisation to the intervention.
• The first mindfulness audio recording becomes available immediately after the introductory video has been completed.
• The subsequent mindfulness audio recordings are sequentially released, at one-day intervals (regardless of participant engagement).
Expected effort: A minimum of one mindfulness audio recording completed daily at participants' convenience. Participantd are encouraged to complete all modules at least once by the end of the 2-week intervention period. Participants are also encouraged to practice bringing mindful awareness to activities throughout their day (‘informal’ mindfulness).

ARM 2: PHYSICAL ACTIVITY
The Physical Activity intervention starts with an introductory infographic explaining the benefits of physical activity for cognition, mental health and physical health, Australian guidelines for physical activity, how to set realistic goals and benefits of even small change, and tips to foster enjoyment of physical activity (e.g., being social, settings goals, tracking progress). It then prompts participants each day to choose a goal to increase their physical activity that day. An evidence-based 7-minute high-intensity circuit training (HICT) protocol, demonstrated via video, is provided as one option for increasing physical activity. Other examples of exercises that are suggested within the intervention are walking, social sport, gardening, yoga, bike riding or dancing.
The modules are made available to participants as follows:
• An introductory module containing infographic-based psychoeducation about the benefits of physical activity is available to participants immediately after randomisation to the intervention (< 5 min to read).
• The Daily goal setting (2-3 minutes) and 7-minute HICT video becomes available immediately after a participant has completed the introductory module.
Expected effort: Participants are encouraged to do some form of physical activity (eg, up to 30 mins) on most days throughout the two-week intervention period, with the 7-minute HICT work out offered as one option of ways they can include more physical activity in their day, or alternatively, increasing steps by 10% weekly.

ARM 3: SLEEP HYGIENE
The Sleep Hygiene intervention centres around four brief, sequential modules covering key sleep hygiene concepts, which are delivered via infographics. Each module takes up to five minutes to read. The content of the modules is as follows:
a) Module 1: Why we sleep? Covers the recommended hours of sleep per night, the impact of lack of sleep on cognition and emotion, benefits of sleep for mental health and physical health, and an introduction to sleep hygiene.
b) Module 2: Sleep habits. covers establishment of regular bedtime and wake time, eliminating or limiting naps, establishing a wind down routine.
c) Module 3: Sleep environment. Covers how to reduce light, noise and temperature disturbance, and ensuring bedding is comfortable; limiting the use of bed to sleep and sex; the impact of electronic devices on sleep; get out of bed when unable to sleep for 20 minutes or more.
d) Module 4: Reducing caffeine, alcohol and nicotine intake close to bedtime; eating a healthy diet; increasing physical activity and avoiding exercise close to bedtime.
The modules are made available to participants as follows:
• Module 1 is available to participants immediately after randomisation to the intervention.
• Module 2 becomes available immediately after a participant has completed Module 1.
• Module 3 becomes available two days after Module 2 is made available (regardless of participant engagement).
• Module 4 becomes available two days after Module 3 is made available (regardless of participant engagement).
Expected effort: All modules completed at least once by the end of the intervention period. Participants are instructed to choose one strategy from each of Module 2 – 4 and implement it daily (total of 3 strategies by end of intervention period). There is no recommended minimum time participants must practice sleep hygiene skills but it is anticipated that implementing the skills will take 10-30 minutes per day.

ASSESSMENT OF ADHERENCE
Throughout the intervention period, participants are asked to log their engagement with the intervention daily via an in-app logging question. For those assigned to the physical activity intervention, they are asked to log how many minutes of physical activity they engaged in that day; for those assigned to the sleep hygiene intervention, they are asked to log how many minutes they spent practicing sleep hygiene skills that day; and for those assigned to the mindfulness intervention, they are asked to log how many minutes of mindfulness practice they engaged in that day. Each log is expected to take less than 5 mins to complete.

FOLLOW-UP PERIOD
All participants will continue to have access to their assigned intervention throughout a 4-week follow-up period (Weeks 5 to 8). At the beginning of this 4-week follow-up period, they are encouraged, via instructional screens within the smartphone app, to practice implementing the skills learned in the intervention. No minimum level of effort or engagement is specified for the follow-up period.
Intervention code [1] 335188 0
Lifestyle
Intervention code [2] 335189 0
Behaviour
Description of the comparator or control
EMA CONTROL ARM
Participants randomised to the EMA control arm will continue doing twice-daily EMA during the intervention period, with each EMA survey expected to take approximately 5 minutes to complete. Similar to the pre-intervention EMA protocol, the EMA control arm protocol will run on a signal-contingent protocol consisting of two daily random prompts to the participant generated by a custom-built smartphone application at a random time within two windows: morning (08:00-10:00) and evening (19:00-21:00). Participants will have up to 60 minutes to respond to the prompt, with a reminder sent after 30 minutes if the prompt has not been responded to.

The control arm EMA questions will differ from the questions used in the pre-intervention EMA in that they aim to provide an assessment of affect and behavioural intentions to act on emotions. Specifically, each EMA prompt will consist of:

• An initial filter question asking whether participants are experiencing any of the emotions drawn from an extended Short Form (12-item) version of the Positive and Negative Affect Schedule (I-PANAS).

• If any emotions are selected on this first filter question, participants will be invited to answer:
- The I-PANAS items for the selected emotions (up to 12); and
- Two follow-up questions exploring behavioural intentions as a result of felt emotions. These will be:
i) How likely are you to do something specifically as a result of how you are feeling right now? (4-item Likert scale: highly unlikely, unlikely, likely, highly likely).
ii) If the response to i) is ‘likely’ or ‘highly likely’: What is it that you are likely to do?

ADHERENCE
Participants are encouraged, via instructional text presented in the app, to complete at least 75% of the EMA prompts.
Control group
Active

Outcomes
Primary outcome [1] 346689 0
Psychological distress
Timepoint [1] 346689 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4; primary timepoint), follow-up (Week 8).
Secondary outcome [1] 467006 0
Depression
Timepoint [1] 467006 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [2] 467007 0
Anxiety
Timepoint [2] 467007 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [3] 467008 0
Anhedonia
Timepoint [3] 467008 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [4] 467009 0
Amotivation
Timepoint [4] 467009 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [5] 467010 0
Level of physical activity
Timepoint [5] 467010 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [6] 467011 0
Sleep quality
Timepoint [6] 467011 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).
Secondary outcome [7] 467012 0
Mindfulness
Timepoint [7] 467012 0
Baseline (Week 0), pre-intervention (Week 2), post-intervention (Week 4), follow-up (Week 8).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include:
1. At least 18 years of age
2. Living in Australia for the duration of the trial
3. Enrolled at a higher education institution
4. Owning an up-to-date smartphone with an active mobile number and internet access
5. Self-rated psychological distress score of 20 or higher on the Kessler 10-item Psychological Distress scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Under the age of 18 years
2. High self-rated suicidal ideation on the Suicide Ideation Attributes Scale (scores greater than or equal to 21)
3. Self-reported psychosis or bipolar disorder
4. Previous participation in the current trial
5. Circumstances that would prevent adequate trial participation in the next 8 weeks (e.g., international travel)
6. Inability to safely undertake a physical activity intervention
7. Participants will be allowed to undertake other concurrent treatments but will be discouraged from starting new treatments while participating

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After completing the baseline questionnaires, pre-intervention EMA period and pre-intervention questionnaires, participants will be randomly allocated by the app to their intervention (or control) arm. The app will only reveal the allocated condition to participants after the EMA period and pre-intervention questionnaires are completed.

Allocation concealment will be guaranteed by preventing access by blinded study staff to the computer system holding randomisation information; and by breaking randomisation codes only once primary data analysis is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised allocation will be performed automatically using a digital clinical trials platform called ‘Conductor’
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was informed by two previous randomised trials evaluating the same four interventions: the Vibe Up AI-enhanced adaptive trial (N=1,282; ACTRN12621001223820) and the Vibe Up Precision Pilot RCT (N=119; ANZCTRN12625000940471).

PRIMARY EFFICACY COMPARISON
The primary efficacy contrast will compare the average of the three active intervention arms with the control arm. The smallest clinically worthwhile difference was specified as 5 points on the DASS-21 total score. Residual standard deviations were highly consistent across our two previous trials (15.57 and 15.01), giving a pooled estimate of 15.69 and a standardised effect size of d=0.319.

Participants will be randomised in a 1:2:2:2 ratio with higher sample sizes for the active arms. Assuming a two-sided alpha=0.05, 80% power, an effect size of d=0.319 and a 1:6 allocation ratio between the control and combined active intervention groups, 637 participants with analysable primary outcome data are required (91 control; 182 per active intervention). Inflating for the 12.2% primary outcome data loss observed across the previous trials gives a target randomised sample of N=728 participants (104 control; 208 per active intervention).

SECONDARY MODERATION ANALYSIS
The planned sample size also provides power for the trial's second major objective of determining whether baseline digital phenotyping markers moderate treatment response.

In the Vibe Up Precision Pilot RCT, nine highly correlated accelerometer-derived movement features were reduced using principal components analysis to a single latent movement phenotype explaining 88.7% of the variance (component loadings 0.85–0.98). This latent movement phenotype significantly moderated treatment response (F(3,98)=4.37, p=0.006, partial eta²=0.118; Cohen's f²=0.134).

Of the 119 pilot participants, 104 (87.4%) had usable digital phenotype and outcome data. Applying this conservative rate to the planned sample gives an anticipated moderation analysis sample of 636 participants. With three numerator degrees of freedom for the omnibus treatment allocation × digital phenotype interaction and alpha=0.05, the study has greater than 80% power to detect a small-to-moderate sized moderation effect (i.e., Cohen's f² of 0.03).

Thus, while the sample size is driven by the primary efficacy comparison, it also provides high power to detect a treatment × digital-phenotype interaction substantially smaller than those observed in the pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
2/12/2027
Actual
Sample size
Target
728
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322102 0
Charities/Societies/Foundations
Name [1] 322102 0
Wellcome Trust
Country [1] 322102 0
United Kingdom
Funding source category [2] 322848 0
Government body
Name [2] 322848 0
National Health and Medical Research Council
Country [2] 322848 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney
Address
Country
Australia
Secondary sponsor category [1] 324994 0
None
Name [1] 324994 0
Address [1] 324994 0
Country [1] 324994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320630 0
The University of New South Wales Committee C
Ethics committee address [1] 320630 0
Ethics committee country [1] 320630 0
Australia
Date submitted for ethics approval [1] 320630 0
01/06/2026
Approval date [1] 320630 0
30/07/2026
Ethics approval number [1] 320630 0
iRECS11694

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151106 0
A/Prof Alexis Whitton
Address 151106 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 151106 0
Australia
Phone 151106 0
+61 2 9065 9046
Fax 151106 0
Email 151106 0
[email protected]
Contact person for public queries
Name 151107 0
Alexis Whitton
Address 151107 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 151107 0
Australia
Phone 151107 0
+61 2 9065 9046
Fax 151107 0
Email 151107 0
[email protected]
Contact person for scientific queries
Name 151108 0
Alexis Whitton
Address 151108 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 151108 0
Australia
Phone 151108 0
+61 2 9065 9046
Fax 151108 0
Email 151108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Raw GPS digital phenotyping data will not be shared.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Trial Protocol.pdf
Informed consent form    Consent form.pdf
Ethical approval    Ethics approval.pdf
Data dictionary    Study measures.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.